MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-PDBX376
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported event cannot be determined.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that the device probe broke in half during a percutaneous novel lithotripsy procedure.The intended procedure was completed with a similar device.The lot number of the device used was not provided.No known device fragments fell into the patient.No patient harm or injury reported.No user injury reported.
Additional Manufacturer Narrative
This supplemental report is to advise that upon further review this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11158286
• Report Number: 3011050570-2021-00013
• Device Sequence Number: 11742441
• Product Code: FEO
• UDI-Device Identifier: 00855279005030
• UDI-Public: 00855279005030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPL-PDBX376
• Device Lot Number: KR973853
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1